By InvitationNot Applicable

Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)

United States14 participantsStarted 2025-05-01

Plain-language summary

The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months. * Patients previously implanted with the RNS System, on stable detection settings enabling reliable detection of electrographic seizures. * Patients willing and able to keep a diary, issue self-forecasts, and follow instructions. * Home equipped with an internet connection. * Informed Consent signed by the subject Exclusion Criteria: * Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase. * Women pregnant at the time of recruitment (later pregnancy not a contra-indication) * Subjects with a history of psychogenic non-epileptic seizures * Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * Vulnerable subjects, including severe cognitive impairment precluding informed consent * Drug or alcohol addiction * Subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.

What they're measuring

Forecast performance

Timeframe: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.

Trial details

NCT IDNCT06952764

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-30